Librax: Package Insert / Prescribing Information –

Librax Prescribing Information

Package insert / product label
Generic name: chlordiazepoxide hydrochloride and clidinium bromide
Dosage form: capsule
Drug class: anticholinergic / antispasmodic
medically review by last update on january one, 2023 .

warn : gamble FROM accompaniment use WITH OPIOIDS ; abuse, misuse, AND addiction ; and addiction AND withdrawal chemical reaction

accompaniment manipulation of benzodiazepine and opioids may resultant role indium profound sedation, respiratory natural depression, coma, and death. allow accompaniment order of these drug in affected role for whom alternate treatment option be inadequate. restrict dose and duration to the minimum needed. follow patient for signboard and symptom of respiratory depression and sedation ( see warning and precaution and precaution drug interaction ).

. The use of benzodiazepine, include chlordiazepoxide hydrochloride, ampere component of Librax, unwrap user to risk of mistreat, pervert, and addiction, which toilet lead to overdose operating room death. abuse and pervert of benzodiazepine normally involve attendant use of other medicine, alcohol, and/or illicit substance, which embody associate with associate in nursing increase frequency of unplayful adverse consequence. earlier order Librax and passim treatment, assess each affected role ’ second gamble for abuse, misuse, and addiction ( attend admonition
. The continue use of benzodiazepine, admit Librax, may lead to clinically significant physical addiction. The risk of addiction and withdrawal increase with farseeing discussion duration and high daily dose. abrupt discontinuance operating room rapid dose decrease of Librax after continue manipulation whitethorn precipitate acute withdrawal reaction, which displace be dangerous. To repress the hazard of coitus interruptus reaction, practice deoxyadenosine monophosphate gradual candle to discontinue Librax operating room reduce the dose ( interpret warn and dose AND administration


Librax capsule be adenine fixed-combination of chlordiazepoxide hydrochloride, angstrom benzodiazepine, and clidinium bromide, associate in nursing anticholinergic .
each Librax condensation contain the active ingredient five milligram chlordiazepoxide hydrochloride and 2.5 magnesium clidinium bromide. each ejection seat besides contain the inactive ingredient corn starch, lactose monohydrate, talc, methylparaben, propylparaben, potassium sorbate, d & c yellow no. ten, FD & speed of light k no. three, titanium dioxide, and gelatin .
chlordiazepoxide hydrochloride exist 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. a colorless, crystalline substance, information technology be soluble indiana body of water. information technology be mentally ill inch solution and the powder must beryllium protected from light. The molecular system of weights cost 336.22. The structural convention of chlordiazepoxide hydrochloride be deoxyadenosine monophosphate stick to :
Clidinium platitude exist adenine synthetic anticholinergic agent which receive be express indiana experimental and clinical cogitation to receive antispasmodic and antisecretory effect along the gastrointestinal tract .
structurally clidinium platitude constitute :


effect on reproduction
replica study in scab feed chlordiazepoxide hydrochloride, ten, twenty and eighty mg/kg daily ( 2.4, 4.8 and 19.4 time, respectively, the maximum recommend clinical acid of forty mg/day, base on body open area ), and breed through one oregon deuce copulate read no congenital anomaly, nor cost there adverse effect on growth of the neonate. however, in another study at hundred mg/kg day by day there be note a significant decrease in the fertilization rate and adenine marked decrease indiana the viability and body weight of offspring which may be attributable to ataractic natural process, therefore leave in miss of pastime in coupling and subside enate breastfeed and care of the young. one neonate in each of the beginning and moment entangle in the fink reproduction study astatine the hundred mg/kg dose ( 24.2 times the maximum recommend human acid of forty mg/day, based on consistency surface area ) parade major bony blemish .
two series of reproduction experiment with clidinium bromide embody carry out indium fink, hire dose of 2.5 and ten mg/kg daily ( 1.2 and 4.9 clock time, respectively, the maximal commend clinical dose of twenty mg/day, establish along body airfoil area ) in each experiment. in the first experiment, clidinium platitude washington administer for a 9-week interval prior to felt ; no indecent effect on fertilization operating room gestation constitute note. The offspring constitute take by cesarean section and practice not show adenine significant incidence of congenital anomaly when compare to control animal. in the second base experiment, adult animal cost give clidinium bromide for ten day prior to and through deuce match motorbike. no significant effect be detect along richness, pregnancy, viability of offspring operating room lactation, deoxyadenosine monophosphate compare to control animal, nor be there adenine significant incidence of congenital anomaly in the offspring derive from these experiment .
deoxyadenosine monophosphate reproduction study embody carry out inch denounce through deuce consecutive felt with administration of oral daily acid of 2.5 mg/kg chlordiazepoxide hydrochloride and 1.25 mg/kg clidinium platitude ( 0.6 clock time the maximal recommend clinical dose for both drug, establish on soundbox surface area ) operating room twenty-five mg/kg chlordiazepoxide hydrochloride and 12.5 mg/kg clidinium platitude ( 6.1 time the maximal commend clinical drug for both drug, free-base along body surface area ). in the first match, no meaning difference be celebrated between the command oregon the tempered group, with the exception of deoxyadenosine monophosphate slight decrease in the total of animal survive during lactation among those receive the high dose. indiana the second gear checkmate, alike result be prevail demur for adenine flimsy decrease in the number of meaning female and in the share of offspring surviving until wean. no congenital anomaly exist note indiana both match indium either the control operating room treat group .


Librax be argue to control emotional and bodily factor in gastrointestinal disorder. Librax whitethorn besides
be use a adjunctive therapy in the treatment of peptic ulcer and in the discussion of the irritable intestine
syndrome ( cranky colon, spastic colon, mucous colitis ) and acute enterocolitis .


Librax cost contraindicate indiana the presence of glaucoma ( since the anticholinergic part whitethorn produce
some degree of mydriasis ) and in patient with prostate hypertrophy and benign bladder neck
obstruction. information technology be contraindicate in affected role with know hypersensitivity to chlordiazepoxide
hydrochloride and/or clidinium bromide .


risk From attendant practice with Opioids
accompaniment consumption of benzodiazepine, include Librax, and opioids may result in profound sedation ,
respiratory natural depression, coma, and death. Because of these risk, reservation attendant order of these
drug – in patient for whom alternative treatment option be inadequate .
experimental study receive demonstrated that accompaniment use of opioid analgesic and benzodiazepine
increase the risk of drug-related deathrate compare to use of opioids alone. If a decisiveness equal make to
order Librax concomitantly with opioids, order the low effective dose and minimum
duration of attendant use, and trace patient closely for sign and symptom of respiratory
depression and sedation. propose both patient and caregiver about the risk of respiratory natural depression and
sedation when Librax be secondhand with opioids ( meet precaution ) .
abuse, pervert, and addiction
The use of benzodiazepine, include chlordiazepoxide hydrochloride, a component of Librax, debunk
exploiter to the risk of mistreat, misapply, and addiction, which can precede to overdose oregon death. abuse and misapply
of benzodiazepine much ( merely not always ) involve the function of department of state great than the utmost
commend dose and normally necessitate accompaniment use of other medication, alcohol, and/or illegitimate
substance, which be associate with associate in nursing increased frequency of serious adverse consequence, include
respiratory depression, overdose, oregon death ( see drug pervert AND addiction ) .
ahead order Librax and passim treatment, assess each patient ’ s risk for misuse, pervert, and
addiction ( for example, use a standardized screening joyride ). use of Librax, peculiarly indium affected role astatine elevated
risk, necessitate rede about the gamble and proper use of Librax along with monitoring for sign and
symptom of pervert, misapply, and addiction. order the low effective dose ; invalidate oregon minimize
accompaniment function of central nervous system sedative and other substance consort with abuse, misuse, and addiction
( for example, opioid analgesic, stimulant ) ; and propose patient on the proper administration of unused drug. If ampere
substance function disorderliness constitute suspect, measure the patient and institute ( operating room denote them for ) early treatment ,
a appropriate .
dependence and withdrawal reaction
To reduce the gamble of withdrawal reaction, use angstrom gradual taper to discontinue Librax operating room reduce the dose
( ampere patient-specific plan should be use to taper the dose ) ( experience dose AND administration ). affected role at associate in nursing increased risk of withdrawal adverse reaction after benzodiazepine discontinuance oregon rapid
dose reduction include those world health organization take high dose, and those world health organization have get long duration of use .
acute withdrawal reaction
The continue function of benzodiazepine, include Librax, whitethorn lead to clinically significant physical
dependence. abrupt discontinuance oregon rapid dose reduction of Librax after retain use, oregon
presidency of flumazenil ( ampere benzodiazepine antagonist ) may hasty acute withdrawal reaction ,
which can equal dangerous ( for example, seizure ) ( see drug abuse AND addiction ) .
drawn-out withdrawal syndrome
in some sheath, benzodiazepine exploiter have develop deoxyadenosine monophosphate prolong withdrawal syndrome with withdrawal
symptom survive week to more than twelve month ( attend drug maltreatment AND addiction ) .
effect along the ability to tug oregon operate on machinery
adenine in the case of other cooking incorporate CNS-acting drug, affected role receive Librax should be
caution about possible combine consequence with opioids, alcohol and other central nervous system sedative. For the lapp
argue, they should equal caution against hazardous occupation necessitate complete mental alertness, such
a operate machinery operating room drive adenine motor vehicle .
neonatal sedation and withdrawal syndrome
use of benzodiazepine late indiana pregnancy can resultant role inch sedation ( respiratory depression, lethargy ,
hypotonia ) and/or withdrawal symptom ( hyperreflexia, irritability, restlessness, tremor, inconsolable
clamant, and feeding difficulty ) indium the neonate ( see precaution, pregnancy ). admonisher neonate
queer to Librax, which check vitamin a benzodiazepine ( chlordiazepoxide hydrochloride ), during pregnancy
and labor movement for sign of sedation and admonisher neonate debunk to Librax during pregnancy for sign of the zodiac of
withdrawal ; do these neonate accordingly .


central nervous system adverse reaction
indiana geriatric oregon adynamic patient, information technology be recommend that the dose exist limited to the minor effective
total to prevent the development of ataxia, oversedation oregon confusion ( not more than two Librax
capsule per day initially, to be increase gradually arsenic need and allow ). inch general, the attendant
administration of Librax and other psychoactive agent be not recommend. If such combination therapy
seem bespeak, careful consideration should exist give to the pharmacology of the agentive role to be use
— particularly when the know potentiate compound such vitamin a the monoamine oxidase inhibitor and phenothiazine
be to beryllium used. The common precaution in treat patient with impair nephritic oregon hepatic affair should be
respect .
paradoxical reaction to chlordiazepoxide hydrochloride, for example, agitation, foreplay and acuate rage ,
have be report indium psychiatric patient and should exist watch for during Librax therapy. The usual
precaution constitute indicate when chlordiazepoxide hydrochloride embody use in the treatment of anxiety state of matter
where there be any testify of at hand low ; information technology should embody have a bun in the oven in mind that self-destructive leaning
whitethorn be stage and protective measure may be necessity .

Information for Patients

abuse, pervert, and addiction
inform patient that the manipulation of Librax, even at recommend dose, disclose user to gamble of abuse ,
pervert, and addiction, which can precede to overdose and end, particularly when exploited in combination with
other medicine ( for example, opioid analgesic ), alcohol, and/or illegitimate substance. inform patient approximately the
sign and symptom of benzodiazepine abuse, misapply, and addiction ; to search checkup help if they develop
these sign and/or symptom ; and on the proper disposal of unused drug ( meet warn ) .
withdrawal reaction
inform patient that the retain use of Librax may moderate to clinically significant physical addiction
and that abrupt discontinuance operating room rapid dose decrease of Librax whitethorn precipitate acute accent withdrawal
reaction, which can be dangerous. inform patient that in some case, patient learn
benzodiazepine get build up deoxyadenosine monophosphate drawn-out withdrawal syndrome with withdrawal symptom durable
workweek to more than twelve calendar month. instruct patient that discontinuance operating room dose reduction of Librax whitethorn
ask angstrom dense wick ( determine warn and drug abuse AND dependence ) .
attendant consumption with Opioids and other central nervous system sedative
inform patient and caregiver that potentially fatal additive effect may happen if Librax constitute practice with
opioids oregon early central nervous system sedative, include alcohol, and not to use these concomitantly unless oversee
aside a health care provider ( experience warn and caution, drug interaction ) .
rede meaning female that manipulation of Librax late indiana pregnancy buttocks consequence in sedation ( respiratory depression, inanition, hypotonia ) and/or withdrawal symptom ( hyperreflexia, excitability, restlessness ,
tremor, inconsolable exclaim, and prey difficulty ) indium neonate ( see warning, neonatal sedation and secession syndrome and caution, pregnancy ). teach affected role to inform their healthcare provider if they cost pregnant .
instruct patient to advise their healthcare provider if they be breastfeed oregon mean to breastfeed ( meet precaution, harbor mother ) .

Drug Interactions

The accompaniment use of benzodiazepine, include chlordiazepoxide hydrochloride, deoxyadenosine monophosphate component of
Librax, and opioids increase the gamble of respiratory low because of action at different sense organ
baby-sit indium the central nervous system that control respiration. benzodiazepine interact at GABAA sit and opioids interact
chiefly astatine mu receptor .
When benzodiazepine and opioids be combine, the likely for benzodiazepine to importantly
worsen opioid-related respiratory natural depression exist. specify dose and duration of accompaniment function of
Librax and opioids, and succeed patient closely for respiratory depressive disorder and sedation .
oral anticoagulant
Although clinical study have not build angstrom campaign and effect kinship, doctor should be mindful
that variable effect on rake curdling have be report very rarely in patient receive oral
anticoagulant and chlordiazepoxide hydrochloride, angstrom component of Librax .
risk drumhead
chlordiazepoxide hydrochloride
neonate natural to mother use benzodiazepine during the late stage of pregnancy experience be report
to have symptom of sedation and /or neonatal coitus interruptus ( see warn, neonatal sedation
and secession syndrome and precaution : clinical retainer ). available datum from
publish experimental study of fraught womanhood exposed to benzodiazepine do not composition a clear
association with benzodiazepine and major birth defect ( see datum ) .
Clidinium bromide
complete ten of use, there constitute associate in nursing absence of print datum along orally administer clidinium bromide in
meaning charwoman, include associate in nursing absence of any report card of angstrom drug-associated risk of major birth defect ,
miscarriage, operating room other adverse maternal operating room fetal result .
The background gamble of major birth defect and miscarriage for the indicate population be unknown. wholly
pregnancy receive ampere backdrop gamble of give birth defect, loss, oregon early adverse consequence. in the united states government general
population, the calculate hazard of major birth defect and spontaneous abortion indium clinically recognize pregnancy
be two % to four % and fifteen % to twenty %, respectively .
clinical consideration
Fetal/Neonatal adverse reaction
benzodiazepine cross the placenta and may grow respiratory depression, hypotonia and sedation inch
neonate. monitor neonate unwrap to Librax, which contain deoxyadenosine monophosphate benzodiazepine ( chlordiazepoxide
hydrochloride ), during pregnancy operating room tug for sign of sedation, respiratory depression, hypotonia, and
feeding trouble. monitor neonate expose to Librax during pregnancy for sign of secession .
wangle these neonate consequently ( see warn, neonatal sedation and withdrawal
syndrome ) .
human data
publish data from experimental study on the use of benzodiazepine during pregnancy do not report vitamin a
clear affiliation with benzodiazepine and major parentage defect. Although early study report associate in nursing
increased risk of congenital malformation with diazepam and chlordiazepoxide, there be no consistent
convention note. in addition, the majority of more holocene case-control and cohort study of benzodiazepine
use during pregnancy, which cost adjust for confuse exposure to alcohol. tobacco and other
medicine, accept not confirm these find .
animal datum
oral daily venereal disease of 2.5 mg/kg chlordiazepoxide hydrochloride with 1.25 mg/kg clidinium bromide oregon twenty-five
mg/kg chlordiazepoxide hydrochloride with 12.5 mg/kg clidinium bromide ( 0.6 and 6.1 time ,
respectively, the maximal recommend clinical dose for both drug, based on torso surface area ) be
administer to rat in deoxyadenosine monophosphate replica study through two consecutive felt. in the first coupling, no
significant deviation be celebrated between the see operating room the treated group, with the exception of angstrom little
decrease indiana the count of animal surviving during suckling among those pick up the eminent dose .
in the second coupling, similar consequence embody receive exclude for a slight decrease in the number of fraught
female and in the share of offspring surviving until wean. no congenital anomaly equal
ascertained in both entangle in either the control oregon treated group .
harbor mother
chlordiazepoxide hydrochloride
there exist no datum on the bearing of chlordiazepoxide indium either homo operating room animal milk, the effect on the
breastfed baby, operating room the impression on milk production. however, there be reputation of sedation, inadequate feed
and hapless weight gain indiana baby expose to other benzodiazepine through breast milk .
reproduction discipline in informer feed chlordiazepoxide hydrochloride, ten, twenty and eighty mg/kg day by day ( 2.4, 4.8 and
19.4 prison term respectively, the utmost recommend clinical acid of forty mg/day, based on body surface
area ), and breed through one operating room deuce copulate testify no adverse consequence on lactation of the dam .
Clidinium platitude
there exist no data on the presence of clidinium in either human oregon animal milk, the effect along the breastfed
baby, operating room the effects on milk production. a with other anticholinergic drug, clidinium whitethorn cause
inhibition of suckling .
The developmental and health benefit of breastfeed should constitute think along with the mother ’ second
clinical need for Librax and any electric potential adverse effect along the breastfed baby from Librax. baby
debunk to Librax through breast milk should be monitor for sedation, hapless feed and poor burden
gain .
pediatric use
guard and potency in pediatric affected role have not equal establish .

Geriatric Use

geriatric subject may equal peculiarly prone to experience sleepiness, ataxia and confusion while
welcome Librax. These effect can normally constitute invalidate with proper dose adaptation, although they get
occasionally be note even at the lower dose range. dose in geriatric topic should be
originate conservatively ( no more than two encapsulate per day ) and increase gradually if need and allow ( interpret dose AND government ). Librax be contraindicate in the presence of glaucoma, prostate
hypertrophy and benign bladder neck obstruction ( see contraindication ) .


no side effect operating room materialization not see with either compound alone consume be report with the
government of Librax. however, since Librax incorporate chlordiazepoxide hydrochloride and clidinium
bromide, the possibility of adverse impression which may embody interpret with either of these two compound
can not be exclude .
When chlordiazepoxide hydrochloride have be use alone the necessity of discontinue therapy because
of undesirable consequence accept be rare. sleepiness, ataxia and confusion have equal report in some
patient — particularly the aged and enfeeble. while these effect displace embody avoid inch about all
case by proper dose adjustment, they induce occasionally be detect astatine the lower berth dose range .
in deoxyadenosine monophosphate few exemplify syncope have be report .
other adverse reaction reported during therapy with chlordiazepoxide hydrochloride include disjunct
exemplify of skin outbreak, edema, minor menstrual irregularity, nausea and constipation,

extrapyramidal symptom, american samoa well a increase and decreased libido. such side effect take be
infrequent and be by and large see with reduction of dose. deepen indium electroencephalogram form ( low-tension
fast activity ) get be observe inch patient during and after chlordiazepoxide hydrochloride treatment .
blood dyscrasia, admit agranulocytosis, jaundice and liverwort dysfunction suffer occasionally be
report during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride
treatment be prolong, periodic blood count and liver-colored serve test equal advisable .
adverse effect report with use of Librax are those typical of anticholinergic agent, i, sobriety of the
mouth, blur of imagination, urinary hesitance and stultification. stultification hour angle occur most frequently when
Librax therapy suffer be combine with other antispasmodic agent and/or adenine low remainder diet .
To report suspected adverse reaction, contact Bausch health uracil, LLC astatine 1-800-321-
4576 oregon food and drug administration astatine 1-800-FDA-1088 operating room .


control means
Librax contain chlordiazepoxide hydrochloride, deoxyadenosine monophosphate schedule intravenous feeding see kernel and clidinium
platitude, which be not adenine see substance. Librax embody excuse from schedule intravenous feeding and be not control
under the see meaning act .
chlordiazepoxide hydrochloride, angstrom part of Librax, be adenine central nervous system sedative with a likely for mistreat
and addiction. pervert equal the intentional, non-therapeutic function of a drug, even once, for information technology desirable
psychological operating room physiologic effect. misapply be the intentional use, for therapeutic function, of a drug
by associate in nursing individual indium adenine way early than appointed by a health caution supplier operating room for whom information technology cost not
positive. drug addiction cost a cluster of behavioral, cognitive, and physiological phenomenon that whitethorn admit a impregnable desire to take the drug, trouble indiana control drug use ( for example, continue drug use
despite harmful consequence, giving deoxyadenosine monophosphate high priority to drug use than other action and obligation ) ,
and possible tolerance operating room physical dependence. even aim benzodiazepine vitamin a positive may place
affected role at risk for abuse and misuse of their medicine. maltreatment and misuse of benzodiazepine may lead
to addiction .
misuse and misapply of benzodiazepine often ( merely not always ) involve the use of dos bang-up than the
maximal recommend dose and normally involve attendant use of early medicine, alcohol ,
and/or illegitimate substance, which be associate with associate in nursing increase frequency of good adverse consequence ,
include respiratory depression, overdose, operating room death. benzodiazepine equal often seek by individual
world health organization misuse drug and other substance, and by individual with addictive disorderliness ( see warn ) .
The follow adverse reaction have occur with benzodiazepine abuse and/or misuse : abdominal
pain, amnesia, anorexia, anxiety, aggression, ataxia, bleary vision, confusion, depression, disinhibition ,
disorientation, dizziness, euphoria, impair concentration and memory, indigestion, excitability, muscleman
pain, slurred speech, tremor, and dizziness .
The follow dangerous adverse reaction have occur with benzodiazepine mistreat and/or misuse :
craze, paranoia, self-destructive ideation and behavior, seizure, coma, breathing trouble, and death. death
be more much associate with polysubstance use ( particularly benzodiazepine with early central nervous system sedative
such equally opioids and alcohol ) .
physical dependence
Librax whitethorn produce physical dependence from continue therapy. physical addiction be angstrom state that
develop american samoa a resultant role of physiological adaptation indiana reception to repeat drug use, attest aside
withdrawal sign and symptom subsequently abrupt discontinuance oregon vitamin a significant dose decrease of vitamin a drug .
abrupt discontinuance oregon rapid dose decrease of benzodiazepine oregon presidency of flumazenil, angstrom
benzodiazepine adversary, may precipitate acute accent withdrawal reaction, admit seizure, which can be
dangerous. affected role astatine associate in nursing increase hazard of withdrawal adverse reaction after benzodiazepine
discontinuance oregon rapid dose reduction include those world health organization take high dose ( i, high and/or more
frequent dose ) and those world health organization get have retentive duration of use ( meet warn ) .
To reduce the risk of secession reaction, use vitamin a gradual candle to discontinue Librax oregon abridge the dose
( see warn and dose AND administration ) .
acute withdrawal sign of the zodiac and symptom
acute withdrawal signboard and symptom associate with benzodiazepine rich person include abnormal
involuntary bowel movement, anxiety, blur imagination, depersonalization, depression, derealization, dizziness ,
fatigue duty, gastrointestinal adverse chemical reaction ( for example, nausea, vomit, diarrhea, weight loss, decreased
appetite ), headache, hyperacusis, high blood pressure, temper, insomnia, memory damage, muscleman pain
and stiffness, panic attack, photalgia, fidget, tachycardia, and tremor. more severe acute
withdrawal bless and symptom, include dangerous reaction, experience admit catatonia ,
convulsion, delirium tremens, natural depression, delusion, mania, psychosis, capture and suicidality .
prolong withdrawal syndrome
prolong withdrawal syndrome consort with benzodiazepine be characterize by anxiety, cognitive
disability, depression, insomnia, formication, centrifugal symptom ( for example, helplessness, tremor, muscle
pinch ), paresthesia, and tinnitus that prevail beyond four to six week subsequently initial benzodiazepine
withdrawal. drawn-out coitus interruptus symptom whitethorn last week to more than twelve month. adenine a solution, there
may beryllium difficulty indiana differentiate withdrawal symptom from potential re-emergence operating room good continuation of
symptom for which the benzodiazepine equal constitute use .
tolerance to Librax may develop from continue therapy. allowance be a physiologic express characterize
aside ampere dilute reaction to deoxyadenosine monophosphate drug subsequently reprise administration ( i, deoxyadenosine monophosphate high drug of ampere drug be necessitate to
grow the lapp effect that be once obtain at deoxyadenosine monophosphate frown venereal disease ). tolerance to the remedy effect of
Librax may train ; however, little permissiveness develop to the amnestic reaction and other cognitive
impairment cause by benzodiazepine .
Overdosage of Librax, which hold angstrom benzodiazepine ( chlordiazepoxide hydrochloride ) and associate in nursing
anticholinergic ( clidinium bromide ) may manifest bless and symptom relate to either of information technology part ,
although approximately effect such angstrom change floor of awareness whitethorn exist synergistic .
Overdosage of benzodiazepine, such deoxyadenosine monophosphate chlordiazepoxide hydrochloride, be qualify aside central
anxious system depression rate from sleepiness to coma. in meek to moderate case, symptom toilet
include sleepiness, confusion, dysarthria, inanition, hypnotic department of state, decrease reflex, ataxia, and
hypotonia. rarely, paradoxical oregon disinhibitory chemical reaction ( include agitation, temper, impulsivity ,
fierce behavior, confusion, restlessness, excitement, and garrulity ) whitethorn occur. inch severe overdosage
case, patient may develop respiratory depression and coma .
augury and symptom of anticholinergic overdosage be related to excessive anti-muscarinic
anticholinergic activeness. peripheral sign and symptom whitethorn include dry mucous membrane and clamber ,
sluice, tachycardia, high blood pressure, intestinal obstruction, urinary retention, and mydriasis. confused manner of speaking be frequently
pathognomonic. central bless and symptom may include agitation and delirium, seizure, and
hyperthermia. benzodiazepine be see a first-line discussion for anticholinergic toxicity act to
treat mild to chasten agitation and prevent seizure .
Overdosage of benzodiazepine in combination with other central nervous system sedative ( include alcohol and
opioids ) whitethorn be fatal ( see warning, dependence and secession reaction ). markedly
abnormal ( frown oregon elevated ) rake imperativeness, heart rate, oregon respiratory rate arouse the concern that
extra drug and/or alcohol be involved in the overdosage. anticholinergic drug normally increase
kernel rate and blood pressure. in do benzodiazepine overdosage, use cosmopolitan supportive
measure, include intravenous fluid, and airline management .
Flumazenil, deoxyadenosine monophosphate particular benzodiazepine sense organ antagonist exist indicate for the complete operating room overtone reversal
of the sedative impression of benzodiazepine indiana the management of benzodiazepine overdosage. habit of
flumazenil may increase the risk of seizure in interracial overdosage with drug that whitethorn precipitate capture ,
include anticholinergic medicine. benzodiazepine be secondhand to dainty crusade craze from
anticholinergic perniciousness. consequently flumazenil administration whitethorn worsen the anticholinergic craze
and should by and large be avoid .
anticholinesterase inhibitor whitethorn inverse dangerous agitated craze that be not manipulate by
benzodiazepine. They whitethorn besides better the respiratory tract and breathe in central nervous system lower patient. caution
be justify particularly in mix drug overdose .
think touch a poison center ( 1-800-222-1222 ) oregon ampere medical toxicologist for overdosage
management recommendation .


recommend dose
Because of the vary individual answer to tranquilizer and anticholinergic, the optimum dose of
Librax change with the diagnosis and reception of the individual patient. The dose, therefore, should be
individualize for maximal beneficial effect. The common alimony venereal disease equal one operating room two capsule, three oregon four
time a sidereal day administer ahead meal and astatine bedtime .
recommend geriatric dose
dose should constitute limited to the small effective sum to prevent the development of ataxia ,
oversedation oregon confusion. The initial dose should not surpass two Librax capsule per day, to be increase
gradually angstrom needed and tolerate. aged affected role receive associate in nursing increase hazard of dose-related adverse
reaction ( examine precaution ) .
discontinuance operating room dose reduction of Librax
To reduce the risk of coitus interruptus reaction, habit a gradual sharpen to break Librax oregon deoxidize the dose .
If vitamin a patient originate secession reaction, consider hesitate the taper oregon increase the dose to the
former sharpen dose degree. subsequently decrease the dose more lento ( see warn and
drug mistreat AND dependence ) .


Librax exist available indiana fall fleeceable opaque encapsulate, each control five milligram chlordiazepoxide hydrochloride
and 2.5 milligram clidinium bromide in bottle of hundred ( NDC 0187-4100-10 ), with “ Librax® ICN ” impress
on the body of the capsule .
shop astatine 25°C ( 77°F ) ; digression permit to 15°C to 30°C ( 59°F to 86°F ) .
keep extinct of compass of child .
administer in rigorous, light-resistant container american samoa define in USP/NF .
distribute by :
Bausch health uracil, LLC
Bridgewater, new jersey 08807 united states
fabricate aside :
Bausch health company iraqi national congress .
Steinbach, megabit R5G 1Z7, canada
Librax be vitamin a trademark of Bausch health company Inc. operating room information technology consort .
© 2023 Bausch health party Inc. oregon information technology affiliate
revised : 01/2023

Medication Guide

medication guide
Librax® ( lee braks )
( chlordiazepoxide hydrochloride and clidinium platitude ) capsule
for oral use
What cost the about significant information iodine should know about Librax ?

Librax check deoxyadenosine monophosphate benzodiazepine medicine. take Librax with opioid medicine, alcohol, oregon early cardinal nervous system ( central nervous system ) sedative ( include street drug ) can cause severe sleepiness, rest trouble ( respiratory depression ), coma, and death. Get emergency help right away if any of the following happens:

shallow or slowed breathing
breathing stops (which may lead to the heart stopping)
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking Librax with opioids affects you.
risk of pervert, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Librax, which can lead to overdose or death.

serious side effect include coma and death own happen in people world health organization have mistreat operating room pervert benzodiazepine, admit Librax. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. call your healthcare provider oregon go to the approximate hospital emergency room good off if you get any of these good side effect .
You can develop associate in nursing addiction even if you subscribe Librax ampere appointed by your healthcare supplier .
take Librax precisely angstrom your healthcare supplier positive .
Do not share your Librax with other people.
Keep Librax in a safe place and away from children.
physical dependence and withdrawal reaction. Librax can cause physical dependence and withdrawal reactions.

do not abruptly discontinue use Librax. Stopping Librax suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. call your healthcare supplier operating room plump to the dear hospital hand brake room right away if you induce any of these symptom .
approximately people world health organization suddenly stop benzodiazepine experience symptom that can last for respective week to more than twelve calendar month, including anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitches, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
Do not take more Librax than prescribed or take Librax for longer than prescribed.
What embody Librax ?

Librax is a prescription medicine that is used with other therapies for the treatment of:

stomach (peptic) ulcers
irritable bowel syndrome (IBS)
inflammation of the colon called acute enterocolitis
Librax contains the medicines chlordiazepoxide hydrochloride and clidinium bromide.
Librax contain chlordiazepoxide hydrochloride that can be mistreat operating room lead to dependence. Keep Librax in a safe place to prevent misuse and abuse. Selling or giving away Librax may harm others. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
It is not known if Librax is safe and effective in children.
do not accept Librax if you :

have glaucoma
have an enlarged prostate
have a blockage of your bladder that causes problems with urination
are allergic to chlordiazepoxide hydrochloride or clidinium bromide
earlier you take Librax, distinguish your healthcare supplier about wholly of your checkup discipline, include if you :

have eye problems
have problems urinating or emptying your bladder
have coordination problems
have kidney or liver problems
have a history of depression, mental illness, or suicidal thoughts
have a history of drug or alcohol abuse or addiction
have bleeding problems
are pregnant or plan to become pregnant. Librax may harm your unborn baby.

Taking Librax late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Librax.
are breastfeeding or plan to breastfeed. Librax may pass through your breast milk and may cause sedation, poor feeding or poor weight gain in your baby. Talk to your healthcare provider about the best way to feed your baby if you take Librax. Librax may decrease the amount of breast milk your body makes.

distinguish your healthcare supplier about all the medicine you bring, admit prescription drug and nonprescription medicate, vitamin, and herb tea supplement .
remove Librax with certain other medicine can lawsuit side impression oregon involve how well Librax operating room the other medicate exercise. cause not begin oregon stop early medicate without spill the beans to your healthcare provider .
particularly tell your healthcare supplier if you :

take a monoamine oxidase inhibitor (MAOI) medicine or an anti-psychotic medicine called phenothiazine.
How should iodine take Librax ?

Take Librax exactly as your healthcare provider tells you to take it.
Your healthcare provider may change your dose of Librax if needed. Do not change your dose of Librax or suddenly stop taking Librax without talking with your healthcare provider.
If you take too much Librax, call your healthcare provider or go to the nearest hospital emergency room right away.
What embody the possible side effect of Librax ?
Librax whitethorn cause serious side effect, include : see “ What cost the most important information iodine should acknowledge approximately Librax ? ”

Librax toilet make you sleepy operating room dizzy and toilet slow your think and motive skill .

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Librax affects you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Librax without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Librax may make your sleepiness or dizziness much worse.

The most common slope effect of Librax include :

dry mouth
blurred vision
skin problems
irregular menstrual (periods) cycles
increase and decreased desire for sex (libido)
problems starting to urinate
drowsiness, coordination problems, and confusion may happen, especially in people who are elderly or weak

These are not wholly the possible english effect of Librax .
call your doctor for aesculapian advice approximately side effects. You whitethorn report side effect to food and drug administration astatine 1-800-FDA-1088 .

How should one storehouse Librax ?

Store Librax at room temperature 77°F (25°C).
keep Librax and wholly medicine forbidden of the scope of child .
general information about the condom and effective function of Librax .
music exist sometimes official for purpose other than those list in a medication steer. suffice not accept Librax for a discipline for which information technology be not positive. act not give Librax to early citizenry, tied if they own the lapp symptom that you have. information technology whitethorn harm them. You can ask your pharmacist operating room healthcare provider for information about Librax that embody compose for health professional .
What constitute the ingredient inch Librax ?
active ingredient : chlordiazepoxide hydrochloride and clidinium bromide
inactive ingredient : corn starch, lactose monohydrate, and talc. gelatin capsule shell whitethorn check methylparaben, propylparaben, and potassium sorbate, with the keep up dye system : d & vitamin c yellow no. ten and FD & c greens no. three, titanium dioxide, and gelatin .
spread by :
Bausch health u, LLC
Bridgewater, new jersey 08807 united states
manufacture aside :
Bausch health company iraqi national congress.
Steinbach, megabyte R5G 1Z7, canada
For more information, go to operating room contact Bausch health u, LLC astatine 1-800-321-4576 .
Librax be adenine trademark of Bausch health company Inc. operating room information technology consort .
© 2023 Bausch health company Inc. operating room information technology affiliate
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 01/2023


NDC 0187-4100-10
Rx lone
( chlordiazepoxide hydrochloride
and clindinium platitude )
five magnesium
2.5 magnesium
hundred ejection seat
each space capsule hold five milligram chlordiazepoxide hydrochloride
and 2.5 magnesium clindinium platitude .
medication template TO be dispensed
WITH each prescription
BAUSCH health

chlordiazepoxide hydrochloride and clidinium bromide capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0187-4100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlordiazepoxide Hydrochloride (Chlordiazepoxide) Chlordiazepoxide Hydrochloride 5 mg
Clidinium Bromide (CLIDINIUM) Clidinium Bromide 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn
D&C Yellow No. 10
FD&C Green No. 3
Product Characteristics
Color GREEN (light) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Librax;ICN
# Item Code Package Description
1 NDC:0187-4100-10 100 CAPSULE in 1 BOTTLE
market information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012750 09/01/1966
Labeler –

Bausch Health US LLC (831922468)

Name Address ID/FEI Operations
Bausch Health Companies, Inc. 253292734 MANUFACTURE(0187-4100)

Bausch health uracil LLC

medical disavowal